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A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers

Last updated on January 19, 2020

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Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Is a healthy adult 18 to 75 years of age, inclusive; healthy is defined as no
clinically relevant abnormalities identified as detailed medical history, full
physical examination, including blood pressure [BP] and pulse rate [PR]measurement,
12-lead electrocardiogram [ECG], and clinical safety laboratory tests

- If female and of childbearing potential (includes women who have been postmenopausal
for have had a negative serum pregnancy test at Screening and a negative urine pregnancy
test result within 24 hours prior to receiving study drug. The site investigator must
ensure that female subjects are not pregnant prior to receiving the first dose of
drug;

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Endoscopic evidence of inflammation, ulceration, erosion, petechiae, or active
bleeding in the esophagus, stomach, pyloric channel, or duodenum at the baseline/
randomization (Day 1) endoscopy (Mucosal Grading Scale score >0);

- Active GI disease (e.g. inflammatory bowel disease), a history of gastroduodenal
ulcers or bleeding, or a history of any gastric or duodenal surgery;

NCT00392080
Pfizer
Completed
A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers

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Descriptive Information
Brief Title  ICMJE A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers
Official Title  ICMJE A Multicenter, Randomized, Placebo And Active-Controlled Study Of The Effect Of CJ-023,423 On The Incidence Gastroduodenal Endoscopic Ulcers In Healthy Subjects
Brief Summary CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer gastrointestinal ulcers compared to patients treated with naproxen and placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: CJ-023,423
    75 mg BID
  • Drug: placebo
    placebo
  • Drug: naproxen
    naproxen
Study Arms  ICMJE
  • Placebo Comparator: 3
    Intervention: Drug: placebo
  • Experimental: 1
    75 mg BID
    Intervention: Drug: naproxen
  • Experimental: 2
    Intervention: Drug: CJ-023,423
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 30, 2008)
340
Original Enrollment  ICMJE
 (submitted: October 23, 2006)
180
Actual Study Completion Date  ICMJE February 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is a healthy adult 18 to 75 years of age, inclusive; healthy is defined as no clinically relevant abnormalities identified as detailed medical history, full physical examination, including blood pressure [BP] and pulse rate [PR]measurement, 12-lead electrocardiogram [ECG], and clinical safety laboratory tests
  • If female and of childbearing potential (includes women who have been postmenopausal for < 2 years ), must be using adequate contraception, must not be lactating and must have had a negative serum pregnancy test at Screening and a negative urine pregnancy test result within 24 hours prior to receiving study drug. The site investigator must ensure that female subjects are not pregnant prior to receiving the first dose of drug;

Exclusion Criteria:

  • Endoscopic evidence of inflammation, ulceration, erosion, petechiae, or active bleeding in the esophagus, stomach, pyloric channel, or duodenum at the baseline/ randomization (Day 1) endoscopy (Mucosal Grading Scale score >0);
  • Active GI disease (e.g. inflammatory bowel disease), a history of gastroduodenal ulcers or bleeding, or a history of any gastric or duodenal surgery;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00392080
Other Study ID Numbers  ICMJE A5231018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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